Health4Kids Intervention Trial for Hispanic Families (H4K)

The University of Texas System (UT)

Status: Completed

Conditions: Pediatric Obesity

Treatments: Other: Education Materials; Behavioral: Face to face counseling session; Behavioral: Newsletters; Behavioral: Telephone Counseling; Behavioral: behavioral counseling; Behavioral: Text messages

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02343367

HSC20130465H

R01HD075936 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The H4K Trial is a randomized controlled trial to improve children's body composition by testing a comprehensive, culturally and linguistically relevant, family-oriented intervention for overweight and obese Hispanic children (ages 6-11) in three pediatric clinics in San Antonio, Texas. The H4K trial will test the efficacy of a 6-month pediatric obesity management intervention (physician counseling plus telephone counseling, newsletters and text messages) compared to standard care (physician counseling only) on three outcomes: 1) body composition (i.e., waist circumference, weight and z-BMI); 2) insulin, glucose and cholesterol levels; and 3) behavior change in physical activity (PA), sedentary behavior and consumption of sugary beverages and fruits and vegetables. The investigators will recruit 230 overweight and obese children-and a parent or guardian for each-and randomize them to the H4K intervention (n = 115 child/parent dyads) or standard care (n = 115 child/parent dyads). The investigators hypothesize that intervention children will significantly improve their body composition, increased their PA levels and diet quality (more fruits and vegetables and less sugary beverages), and decrease their sedentary activity, compared to children in standard care. If successful, this study will generate new scientific knowledge about effective Hispanic family-based approaches for obesity prevention with high potential for replication in underserved areas across the nation.

Full description

Given the continuing rise of the U.S. Hispanic population, reversing the Hispanic childhood obesity epidemic is critical to the nation's future health. Mexican American children and those from socioeconomically disadvantaged families often are far more overweight and obese than their peers, heightening their risk for obesity-related health complications. Our proposed randomized controlled trial, the Health4Kids (H4K) Trial for Hispanic Families, aims to improve Hispanic children's body composition by testing a comprehensive, culturally and linguistically relevant, family-oriented intervention for overweight and obese (body mass index (BMI) between the 85th and 99.9thth (<99th) percentile for age and gender) Hispanic children ages 6-11 in pediatric clinics in San Antonio, Texas, a largely Hispanic city. Our team, formed during our pilot research funded by the Centers for Medicare and Medicaid Services (1H0CMS030457), unites academic investigators and community partners with experience working together to conduct behavioral and clinical interventions and outreach with Hispanics. The H4K trial will test the efficacy of a 6-month pediatric obesity management intervention (physician counseling plus telephone counseling, newsletters and text messages) compared to standard care (physician counseling only) on three outcomes: 1) body composition (i.e., waist circumference, weight and z-BMI); 2) insulin, glucose and cholesterol levels; and 3) behavior change in physical activity (PA), sedentary behavior and consumption of sugary beverages and fruits and vegetables. We will recruit 230 overweight and obese children-and a parent or guardian for each-and randomize them to the POM intervention (n = 115 child/parent dyads) or standard care (n = 115 child/parent dyads). From a baseline, we will measure the impact of the trial on the primary outcome (body composition) and secondary outcomes (insulin, glucose and cholesterol levels and several specific health behavior changes) at 1 month, 6 and 12 months post-randomization. We also will evaluate the critical role of parenting strategies and changes in the home environment as mediators of intervention effects. We hypothesize that intervention children will significantly improve their body composition, increased their PA levels and diet quality (more fruits and vegetables and less sugary beverages), and decrease their sedentary activity, compared to children in standard care. If successful, this study will generate new scientific knowledge about effective Hispanic family-based approaches for obesity prevention with high potential for replication in underserved areas across the nation.

Enrollment: 518 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A child is eligible for the POM trial for meeting the following criteria:

  • identified by parent or legal guardian as Hispanic
  • age 6-11
  • overweight or obese (BMI between the 85th and 99.9thth (<99th) percentile for age and gender
  • one parent/guardian that the child resides with full-time must agree to participate in intervention and evaluation activities.

Exclusion criteria

• A child will be excluded if he/she has:

  • a mental, emotional, or physical handicap identified by parents or health care provider that may interfere with study participation
  • a diagnosis of cardiovascular, pulmonary, or digestive disease
  • parent without a cell phone
  • parent unable or not willing to receive text messages
  • child or parent planning to move from the local area within the time span of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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518 participants in 2 patient groups

Standard Care

Active Comparator group

Description:

Brief patient-centered behavioral counseling using the Healthy Lifestyle Prescription, health education materials and a community resource guide. Follow-up visits scheduled at 1, 6, and 12 months. Parent receives weekly general health education cell phone text messages for 12 months

Treatment:

Behavioral: Text messages

Behavioral: behavioral counseling

Other: Education Materials

Pediatric Obesity Management

Experimental group

Description:

All elements of standard care plus a family-based face to face counseling session with a health educator, telephone counseling, mailed newsletters and regularly scheduled cell phone text messages with tips and motivational messages for healthy eating and PA, as well as information on community events and resources.

Treatment:

Behavioral: Text messages

Behavioral: behavioral counseling

Other: Education Materials

Behavioral: Telephone Counseling

Behavioral: Newsletters

Behavioral: Face to face counseling session